# FDA 483 - Evi Labs - January 15, 2025

Source: https://www.keypedia.com/records/483/evi-labs/ea556423-6b1d-42b1-bdcc-1c6022921cac

> FDA 483 for Evi Labs on January 15, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Evi Labs
- Inspection Date: 2025-01-15
- Product Type: drugs
- Office Name: Florida District Office
- Summary: Evi Labs LLC in Medley, FL, received a Form 483 with 10 observations following an inspection from January 9-15, 2025. The inspection revealed significant deficiencies across laboratory controls, facilities and equipment, materials, production, and quality systems, indicating a pervasive lack of fundamental cGMP compliance. Key issues include inadequate product testing, lack of stability data, poor data integrity controls, and insufficient quality unit oversight for OTC drug manufacturing.

## Related Documents

- [WARNING_LETTER - 2025-01-15](https://www.keypedia.com/records/warning_letter/evi-labs/cd3d6842-265a-402e-8578-1c371257da51)

## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.keypedia.com/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)
- [Rodney L. Tizzle](https://www.keypedia.com/people/rodney-l-tizzle/6cd74272-6213-43c4-b030-91983e94ee5d)
- [Andrew O. Ejiofor](https://www.keypedia.com/people/andrew-o-ejiofor/6f256c75-79a4-41a0-a51b-480d5db8f3da)
- [Rodney L. Tinzie](https://www.keypedia.com/people/rodney-l-tinzie/6f2bba0d-14c2-4eb5-b6a0-ececb5d7d162)
- [Sandrea A. Munroe](https://www.keypedia.com/people/sandrea-a-munroe/e7808ea0-c592-4547-a54c-fce152f8ffc7)

Company: https://www.keypedia.com/companies/evi-labs/0713d12b-117d-4b0b-a25e-2df2a5682fc4

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9